Uqora All-in-one Uti Emergency Kit

Uqora All-in-one Uti Emergency Kit
SPL v2
SPL
SPL Set ID ebde96d2-e1f2-26b1-e053-2a95a90a2fb1
Route
ORAL
Published
Effective Date 2022-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Methenamine (162 mg) Salicylic Acid (162.5 mg) Phenazopyridine (99.5 mg)
Inactive Ingredients
Sodium Bicarbonate Triethyl Citrate Fd&c Yellow No. 6 Hypromelloses Fd&c Red No. 40 Benzoic Acid Croscarmellose Sodium Magnesium Stearate Methacrylic Acid-ethyl Acrylate Copolymer (1:1) Type A Cellulose, Microcrystalline Silicon Dioxide Stearic Acid Sodium Lauryl Sulfate Talc Titanium Dioxide Triacetin Polyethylene Glycol, Unspecified Sodium Starch Glycolate Type A Lactose, Unspecified Form Povidone, Unspecified Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: p99 Shape: round Shape: oval Color: red Color: brown Size: 11 mm Size: 9 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-10-17

Description

Drug Facts


Medication Information

Description

Drug Facts

Section 42229-5

Drug Facts

Section 53413-1

Distributed by Uqora, Inc.

3043 4th Avenue, San Diego, CA 92103

[email protected]

For questions or concerns please contact (888) 313-1372

Section 55105-1
Active ingredients (in each tablet) Purpose
Methenamine 162mg Antibacterial

Sodium Salicylate 162.5mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Analgesic (pain reliever)

Active ingredient (in each tablet)

Purpose
Phenazopyridine Hydrochloride 99.5mg Urinary Tract Analgesic

Do Not Use

Do not use:

  • If you are allergic to salicylates (including aspirin) ( UTI Infection Control only )
  • If you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your doctor ( UTI Pain Relief only)
Uti Pain Relief

Fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions.

Additional Items

2 diagnostic UTI test strips (Directions Enclosed)

Other information

  • store at room temperature 59-86 F (15-30 C) out of direct sunlight. Do not refrigerate or freeze
  • For in-vitro (external) diagnostic use.
Uti Infection Control

Temporarily relieves:

  • pain and burning
  • frequency and urgency of urination
Ask A Doctor Before Use

Ask a doctor before use if you have:

  • frequent, burning urination for the first time (UTI Infection Control only)
  • the stomach bleeding warning applying to you (UTI Infection Control only)
  • history of stomach problems, such as heartburn (UTI Infection Control only)
  • high blood pressure (UTI Infection Control only)
  • heart disease (UTI Infection Control only)
  • liver cirrhosis (UTI Infection Control only)
  • bleeding problems (UTI Infection Control only)
  • diuretic use (UTI Infection Control only)
  • ulcers (UTI Infection Control only)
  • kidney disease
  • a sodium restricted diect (UTI Infection Control only)
  • reached age 60 or older (UTI Infection Control only)
  • allergies to foods, preservatives or dyes (UTI Pain Relief only)
  • had a hypersensitive reaction to phenazopyridine (UTI Pain Relief only)
Principal Display Panel

uqora

Urinary Care

Maximum Strength UTI Pain Relief Included

ALL-IN-ONE

UTI EMERGENCY KIT

2 Day Supply Includes:

Test Strips

  • Test for a possible UTI at home in 2 minutes
  • 2 Test Strips

Infection Control

  • Helps slow infection progression until you're able to see a doctor
  • 12 Tablets (Methenamine & Sodium Salicylate (NSAID)

Max Strength Pain Relief

  • Max strength relief to quickly soothe UTI pain & burning
  • 12 Tablets (99.5mg Phenazopyridine Hydrochloride)

Packaged for convenience. Not intended to replace medical care.

When Using This Product

When using this product:

  • do not take more than the recommended dosage (UTI Infection Control only)
  • stomach upset may occur, taking this product with or after meals may reduce stomach upset (UTI Pain Relief only)
  • your urine will become reddish-orange in color. This is not harmful, but care should be taken to avoid staining clothing or other items. (UTI Pain Relief only)

Stop Use and Ask A Doctor

Stop use and ask a doctor if:

  • product has been used for 3 days (UTI Infection Control only)
  • ringing in the ears (UTI Infection Control only)
  • you experience any of the following signs of stomach bleeding: ■ feel faint ■ vomit blood ■ have bloody or black stool ■ have stomach pain or upset that gets worse or lasts (UTI Infection Control only)
  • your symptoms last for more than 2 days (UTI Pain Relief only)
  • you suspect you are having an adverse reaction to the medication (UTI Pain Relief only)
If Pregnant Or Breast Feeding



Keep Out of the Reach of Children

Keep out of the reach of children.In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222

Do Not Exceed (uti Pain Relief Only)

Do not exceed recommended dosage

Reye's Syndrome (uti Infection Control Only)

Reye’s syndrome:Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this

product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Long Term Administration (uti Pain Relief Only)

Long-term administration of phenazopyridine hydrochloride has induced neoplasia in rats (large intestine) and mice (liver). Although

no association between phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.

Stomach Bleeding Warning (uti Infection Control Only)

Stomach bleeding warning:This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you

  • are 60 or older
  • have stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed
Ask A Doctor Or Pharmacist Before Use (uti Infection Control Only)

Ask a doctor or pharmacist before use if you are:

  • taking any other drug containing an NSAID (prescription or non-prescription)
  • taking a blood thinning (anticoagulant), steroid, diabetes, gout or arthritis drug

Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

Section 53413-1 (53413-1)

Distributed by Uqora, Inc.

3043 4th Avenue, San Diego, CA 92103

[email protected]

For questions or concerns please contact (888) 313-1372

Section 55105-1 (55105-1)
Active ingredients (in each tablet) Purpose
Methenamine 162mg Antibacterial

Sodium Salicylate 162.5mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Analgesic (pain reliever)

Active ingredient (in each tablet)

Purpose
Phenazopyridine Hydrochloride 99.5mg Urinary Tract Analgesic

Do Not Use

Do not use:

  • If you are allergic to salicylates (including aspirin) ( UTI Infection Control only )
  • If you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your doctor ( UTI Pain Relief only)
Uti Pain Relief (UTI Pain Relief)

Fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions.

Additional Items

2 diagnostic UTI test strips (Directions Enclosed)

Other information

  • store at room temperature 59-86 F (15-30 C) out of direct sunlight. Do not refrigerate or freeze
  • For in-vitro (external) diagnostic use.
Uti Infection Control (UTI Infection Control)

Temporarily relieves:

  • pain and burning
  • frequency and urgency of urination
Ask A Doctor Before Use

Ask a doctor before use if you have:

  • frequent, burning urination for the first time (UTI Infection Control only)
  • the stomach bleeding warning applying to you (UTI Infection Control only)
  • history of stomach problems, such as heartburn (UTI Infection Control only)
  • high blood pressure (UTI Infection Control only)
  • heart disease (UTI Infection Control only)
  • liver cirrhosis (UTI Infection Control only)
  • bleeding problems (UTI Infection Control only)
  • diuretic use (UTI Infection Control only)
  • ulcers (UTI Infection Control only)
  • kidney disease
  • a sodium restricted diect (UTI Infection Control only)
  • reached age 60 or older (UTI Infection Control only)
  • allergies to foods, preservatives or dyes (UTI Pain Relief only)
  • had a hypersensitive reaction to phenazopyridine (UTI Pain Relief only)
Principal Display Panel

uqora

Urinary Care

Maximum Strength UTI Pain Relief Included

ALL-IN-ONE

UTI EMERGENCY KIT

2 Day Supply Includes:

Test Strips

  • Test for a possible UTI at home in 2 minutes
  • 2 Test Strips

Infection Control

  • Helps slow infection progression until you're able to see a doctor
  • 12 Tablets (Methenamine & Sodium Salicylate (NSAID)

Max Strength Pain Relief

  • Max strength relief to quickly soothe UTI pain & burning
  • 12 Tablets (99.5mg Phenazopyridine Hydrochloride)

Packaged for convenience. Not intended to replace medical care.

When Using This Product

When using this product:

  • do not take more than the recommended dosage (UTI Infection Control only)
  • stomach upset may occur, taking this product with or after meals may reduce stomach upset (UTI Pain Relief only)
  • your urine will become reddish-orange in color. This is not harmful, but care should be taken to avoid staining clothing or other items. (UTI Pain Relief only)

Stop Use and Ask A Doctor (Stop Use And Ask A Doctor)

Stop use and ask a doctor if:

  • product has been used for 3 days (UTI Infection Control only)
  • ringing in the ears (UTI Infection Control only)
  • you experience any of the following signs of stomach bleeding: ■ feel faint ■ vomit blood ■ have bloody or black stool ■ have stomach pain or upset that gets worse or lasts (UTI Infection Control only)
  • your symptoms last for more than 2 days (UTI Pain Relief only)
  • you suspect you are having an adverse reaction to the medication (UTI Pain Relief only)
If Pregnant Or Breast Feeding (If Pregnant or Breast Feeding)



Keep Out of the Reach of Children (Keep Out Of The Reach Of Children)

Keep out of the reach of children.In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222

Do Not Exceed (uti Pain Relief Only) (Do Not Exceed (UTI Pain Relief Only))

Do not exceed recommended dosage

Reye's Syndrome (uti Infection Control Only) (Reye's Syndrome (UTI Infection Control Only))

Reye’s syndrome:Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this

product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Long Term Administration (uti Pain Relief Only) (Long Term Administration (UTI Pain Relief Only))

Long-term administration of phenazopyridine hydrochloride has induced neoplasia in rats (large intestine) and mice (liver). Although

no association between phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.

Stomach Bleeding Warning (uti Infection Control Only) (Stomach Bleeding Warning (UTI Infection Control Only))

Stomach bleeding warning:This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you

  • are 60 or older
  • have stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed
Ask A Doctor Or Pharmacist Before Use (uti Infection Control Only) (Ask A Doctor Or Pharmacist Before Use (UTI Infection Control Only))

Ask a doctor or pharmacist before use if you are:

  • taking any other drug containing an NSAID (prescription or non-prescription)
  • taking a blood thinning (anticoagulant), steroid, diabetes, gout or arthritis drug

Advanced Ingredient Data


Raw Label Data

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